Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Corporate Authors:
      PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA)
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Anesthesia, General*/adverse effects ; Surgical Procedures, Operative*/adverse effects; Intraoperative Care/*methods ; Lung/*physiopathology ; Lung Diseases/*prevention & control ; Obesity/*complications ; Positive-Pressure Respiration/*methods; Body Mass Index ; Clinical Protocols ; Female ; Humans ; Intraoperative Care/adverse effects ; Lung Diseases/diagnosis ; Lung Diseases/etiology ; Lung Diseases/physiopathology ; Male ; Obesity/diagnosis ; Obesity/physiopathology ; Positive-Pressure Respiration/adverse effects ; Protective Factors ; Research Design ; Risk Factors ; Time Factors ; Treatment Outcome
    • Abstract:
      Background: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.
      Methods/design: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m 2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH 2 O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH 2 O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.
      Discussion: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.
      Trial Registration: ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
    • Comments:
      Erratum in: Trials. 2017 Jun 1;18(1):247. (PMID: 28571581)
    • References:
      BMJ. 2015 Jul 14;351:h3646. (PMID: 26174419)
      Eur J Anaesthesiol. 2015 Jul;32(7):458-70. (PMID: 26020123)
      J Biomed Inform. 2009 Apr;42(2):377-81. (PMID: 18929686)
      Anesth Analg. 2009 Nov;109 (5):1511-6. (PMID: 19843790)
      Obes Surg. 2003 Aug;13(4):605-9. (PMID: 12935363)
      Lancet Respir Med. 2016 May;4(5):407-18. (PMID: 27304558)
      Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25. (PMID: 7074238)
      Anesthesiology. 2009 Nov;111(5):979-87. (PMID: 19809292)
      Intensive Care Med. 2014 Jul;40(7):950-7. (PMID: 24811940)
      Crit Care Med. 2003 Apr;31(4):1250-6. (PMID: 12682500)
      Anesth Analg. 1998 Sep;87(3):654-60. (PMID: 9728848)
      JAMA. 2012 Jun 20;307(23):2526-33. (PMID: 22797452)
      Eur J Anaesthesiol. 2010 Jun;27(6):508-13. (PMID: 20404729)
      Anesth Analg. 2006 Jan;102(1):298-305. (PMID: 16368847)
      N Engl J Med. 2015 Feb 19;372(8):747-55. (PMID: 25693014)
      Lancet. 2014 Aug 9;384(9942):495-503. (PMID: 24894577)
      Aliment Pharmacol Ther. 2012 Jun;35(11):1245-56. (PMID: 22506515)
      Anesth Analg. 2008 Nov;107(5):1707-13. (PMID: 18931236)
      Dan Med J. 2012 Jul;59(7):A4464. (PMID: 22759844)
      JAMA. 2010 Mar 3;303(9):865-73. (PMID: 20197533)
      N Engl J Med. 2013 Aug 1;369(5):428-37. (PMID: 23902482)
      Surgery. 2015 Feb;157(2):362-80. (PMID: 25616950)
      Am J Respir Crit Care Med. 2011 May 15;183(10 ):1354-62. (PMID: 21297069)
      Curr Opin Anaesthesiol. 2016 Jun;29(3):421-9. (PMID: 26982116)
      Anesthesiology. 2015 Aug;123(2):423-33. (PMID: 26039328)
      Circulation. 2010 Oct 19;122(16 Suppl 2):S345-421. (PMID: 20956256)
      Anesthesiology. 2014 Aug;121(2):400-8. (PMID: 25050494)
      Am Rev Respir Dis. 1981 Jun;123(6):659-64. (PMID: 7271065)
      Acta Chir Belg. 2013 Nov-Dec;113(6):397-400. (PMID: 24494465)
      Anesthesiology. 2015 Sep;123(3):692-713. (PMID: 26120769)
      Lancet Respir Med. 2016 Apr;4(4):272-80. (PMID: 26947624)
      Anesthesiology. 2015 Jul;123(1):66-78. (PMID: 25978326)
      Crit Care. 2008;12(4):R90. (PMID: 18625051)
      N Engl J Med. 2000 May 4;342(18):1301-8. (PMID: 10793162)
      Anesth Analg. 2015 Nov;121(5):1231-9. (PMID: 26332856)
      Br J Haematol. 2009 Apr;145(1):24-33. (PMID: 19222477)
      Br J Anaesth. 2012 May;108(5):768-75. (PMID: 22401881)
      Lancet. 2009 Sep 26;374(9695):1113-7. (PMID: 19782877)
      Crit Care. 2004 Aug;8(4):R204-12. (PMID: 15312219)
      Anesthesiology. 2010 Dec;113(6):1338-50. (PMID: 21045639)
      Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. (PMID: 20608558)
      Anesthesiology. 2011 Jun;114(6):1354-63. (PMID: 21478734)
      Crit Care Med. 2015 Oct;43(10):2155-63. (PMID: 26181219)
      J Crit Care. 2013 Aug;28(4):533.e9-15. (PMID: 23369521)
      J Appl Physiol (1985). 2009 Mar;106(3):757-65. (PMID: 19074576)
      Chest. 1996 Jan;109(1):144-51. (PMID: 8549177)
      Anesthesiology. 2014 Aug;121(2):219-31. (PMID: 24901240)
      Anesthesiology. 2013 Jun;118(6):1307-21. (PMID: 23542800)
      N Engl J Med. 2013 Nov 28;369(22):2126-36. (PMID: 24283226)
      Br J Anaesth. 2014 Sep;113(3):501-7. (PMID: 24833726)
      Lancet Respir Med. 2014 Dec;2(12):1007-15. (PMID: 25466352)
      Anesthesiology. 1999 Nov;91(5):1221-31. (PMID: 10551570)
      Circulation. 2007 Nov 27;116(22):2634-53. (PMID: 17951284)
      Anaesthesia. 2012 Sep;67(9):999-1008. (PMID: 22708696)
      Acta Anaesthesiol Scand. 1978;22(3):241-8. (PMID: 354305)
      World J Gastroenterol. 2014 Jan 7;20(1):274-81. (PMID: 24415882)
    • Grant Information:
      R34 HL123438 United States HL NHLBI NIH HHS; UL1 TR000135 United States TR NCATS NIH HHS
    • Contributed Indexing:
      Investigator: A Güldner; R Huhle; C Uhlig; L Vivona; A Bergamaschi; R Rossaint; A Stevanovic; T Treschan; M Schaefer; P Kienbaum; R Laufenberg-Feldmann; L Bergmann; F Ebner; L Robitzky; P Mölders; M Unterberg; C Busch; M Achilles; A Menzen; H Freesemann; C Putensen; H Machado; C Cavaleiro; C Ferreira; D Pinho; M Carvalho; S Pinho; M Soares; DS Castro; F Abelha; R Rabico; E Delphin; J Sprung; TN Weingarten; TA Kellogg; YN Martin; TJ McKenzie; SJ Brull; JR Renew; H Ramakrishna; A Fernandez-Bustamante; K Balonov; HR Baig; A Kacha; JC Pedemonte; F Altermatt; MA Corvetto; S Paredes; J Carmona; A Rolle; E Bos; C Beurskens; B Veering; H Zonneveldt; C Boer; M Godfried; B Thiel; B Kabon; C Reiterer; J Canet; R Tolós; M Sendra; M González; N Gómez; C Ferrando; T Socorro; A Izquierdo; M Soro; M Granell Gil; MJ Hernández Cádiz; E Biosca Pérez; A Suarez-de-la-Rica; M Lopez-Martinez; I Huercio; E Maseda; J Yagüe; A Cebrian Moreno; E Rivas; M Lopez-Baamonde; H Elgendy; M Sayedalahl; AR SIibai; A Yavru; N Sivrikoz; M Karadeniz; P Corman Dincer; HO Ayanoglu; G Tore Altun; AD Kavas; B Dinc; B Kuvaki; S Ozbilgin; D Erdogan; C Koksal; S Abitagaglu; C Aurilio; P Sansone; CM Pace; V Donatiello; S Mattera; P Nazareno; S Di Colandrea; S Spadaro; CA Volta; R Ragazzi; S Ciardo; L Gobbi; P Severgnini; A Bacuzzi; E Brugnoni; A Gratarola; C Micalizzi; F Simonassi; P Malerbi; A Carboni; MJ Licker; A Dullenkopf; N Goettel; V Nesek Adam; M Karaman Ilić; V Klaric; B Vitkovic; M Milic; M Zupcic; L De Baerdemaeker; S De Hert; B Heyse; J Van Limmen; Y Van Nieuwenhove; E Mertens; A Neyrinck; J Mulier; D Kahn; D Godoroja; M Martin-Loeches; S Vorotyntsev; V Fronchko; I Matot; O Goren; L Zac; T Gaszynski; J Laffey; G Mills; P Nalwaya; M Mac Gregor; J Paddle; P Balaji; F Rubulotta; A Adebesin; M Margarson; S Davies; D Rangarajan; C Newell; M Shosholcheva; F Papaspyros; V Skandalou; P Dzurňáková
      Keywords: Mechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuver
    • Molecular Sequence:
      ClinicalTrials.gov NCT02148692
    • Publication Date:
      Date Created: 20170430 Date Completed: 20180319 Latest Revision: 20190708
    • Publication Date:
      20221213
    • Accession Number:
      PMC5410049
    • Accession Number:
      10.1186/s13063-017-1929-0
    • Accession Number:
      28454590